NCT07625657 · ClinQure, Inc.
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
What this study is about
This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear.
View original scientific description
This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia. The study will also look at how well patients tolerate the procedure by checking for side affects during the procedure. Finally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..
Interventions
DEVICE
CLiKX® Tympanostomy Tube Delivery System
The CLiKX device is an automated, sensor-optimized, partially reusable handheld surgical device used for tympanostomy tube placement. It consists of multiple components assembled before use and disassembled after the procedure. The device includes integrated, pre-programmed software that controls its mechanical actions. The software is locked, cannot be modified by users, and does not perform diagnostic or therapeutic decision-making. Instead, it provides visual cues and applies controlled force to assist the procedure. Compared to manual techniques, the CLiKX device automates key steps, including creating a precise slit incision using regulated force. This approach is designed to reduce operator variability, minimize trauma to the tympanic membrane, and improve accuracy of tube placement. Clinicians retain full control over targeting throughout the procedure.
Primary outcome measures
Effectiveness of C-TTDS for tympanostomy tube placement
Time frame: At time of procedure (first or second attempt)
Effectiveness will be determined by success at the end of each ear tube procedure. Effectiveness is defined as the successful incision in the tympanic membrane and delivery of tympanostomy tube across the tympanic membrane in the proper position after a maximum of 2 insertion attempts per indicated ear. An insertion attempt is defined as an incision in the tympanic membrane by the C-TTDS
Safety of C-TTDS for tympanostomy tube placement
Time frame: At time of procedure (first or second attempt)
Safety will be assessed by incidence, severity and relatedness of device related adverse events occurring during the overall procedure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject is scheduled to undergo tympanostomy tube insertion.
- Subject is ≥ 6 months old at the time of informed consent.
- Subject has an ear canal diameter of ≥ 4 mm.
- Subject is able and willing to provide informed consent or subject's parent/guardian is able and willing to provide informed consent and subject is able and willing to provide assent as age appropriate (age 7 years to 21 years old).
Exclusion criteria
- Subjects who are pregnant as confirmed by the institution's standard pre- surgery practice.
- Subjects with known adverse reaction to anesthesia.
- Subjects with atrophic, dimeric, severely thinned and scarred, severely thickened, severely retracted, atelectatic or perforated tympanic membrane.
- Subjects with otitis externa.
- Subjects with active acute otitis media.
- Subjects with an ear canal diameter \< 4 mm.
- Ear drums that are overly vertical or horizontal
- Subjects with an anatomy that precludes visualization and access to the tympanic membrane, in the opinion of the investigator.
- Subjects with any condition that, in the opinion of the investigator, may place the subject at greater risk.
- Subjects with suspected middle ear tumors or vascular lesions.
- Subjects diagnosed with acute sensorial hearing loss
- Subjects with a history of surgery involving the ear drum.
- Subjects with hemotympanum.
- Subject is not able or willing to comply with study procedures and follow-up requirements, in the opinion of the investigator.
Where
- Louisville, Kentucky
- Mesquite, Texas
Collaborators
NousQ Pte Ltd
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations